November 2012 Edition Vol.6, Issue 7

Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape

Recent Surge in FDA Approvals Shakes up the Oncology Promotional Landscape

By Bill Bowman, JD

What a year 2012 has been. So far this year, the FDA has approved ten new brands for cancer treatment and eight supplemental applications were cleared for existing products. Much of this activity has occurred since the onset of summer, including eight new brands and four supplemental applications. Table 1 provides a summary of 2012 year-to-date FDA activity.

This rapid influx of so many new agents has dramatically altered the level of promotional activity, as companies vie for increasingly limited face time with busy oncologists. Further, the FDA approved six new oncologic products in 2011 and granted sNDAs for two more. The net effect of all these recent product launches is a fiercely competitive marketplace that can shift dramatically on a monthly basis.

OBR has collaborated with ImpactRx to evaluate the changing promotional landscape due to the rollout of all these new brands. ImpactRx employs a proprietary database of 425 practicing oncologists equipped with iPhones/iPads, enabling physicians to enter information on company representative visits at the point of engagement. This mobile research model provides both a marketplace view in “real time” and longitudinal tracking of changes in oncologists’ attitudes and behaviors.  

ImpactRx tapped into this database of approximately 3,000 monthly representative visits (including sales representatives, medical science liaisons, clinical study coordinators, and reimbursement specialists) with oncologists to determine which brands are being discussed most frequently. In order to assess the most up-to-date impact of these new product approvals, we will first focus on promotional activity for the month of September 2012 and compare it with activity for the prior month, based on the number of representative visits. Later, we will compare September 2012 with September 2011 and assess longer-term trends going back to 2010.

When Table 2 is compared to the earlier table listing new product approvals, we quickly note that three of the brands in the Top 10 list (Xtandi, Kyprolis and Zaltrap) were approved since this past summer. In particular, Xtandi (indicated for castration resistant prostate cancer) has quickly captured second place behind the reigning leader Afinitor, which was also recently cleared for marketing of advanced hormone receptor-positive/HER2 negative breast cancer. 

Zaltrap (metastatic colorectal cancer) is also rapidly gaining on the leaders. Erbitux remained in the Top 10 in spite of the activity generated by these new arrivals, perhaps owing to its recently approved sBLA for first-line treatment of KRAS mutation negative mCRC. This is not surprising, as breast, prostate and colorectal are “big tumors” where one would expect a high volume of promotional activity. Yet, Kyprolis (multiple myeloma) and Jakafi (myelofibrosis; approved in November 2011) target less common malignancies and each of these made the Top 10. [Note: Stivarga (also approved for metastatic colorectal cancer) did not make the September list due to its late breaking approval that month and Abraxane was just cleared for its new indication in advanced NSCLC.]

If we take this analysis a step further and compare promotional activity for September 2012 versus September 2011, more striking differences are noted (Table 3). Most of the leaders from a year ago no longer appear in the current Top 10 list. The cytotoxic agent Jevtana (castration-resistant prostate cancer), in particular, has dropped from 4th to 44th position. This is undoubtedly based to a large extent on the launches of Zytiga and more recently Xtandi. Both of these brands are also indicated for castration-resistant prostate cancer and are also aiming to be used in the chemotherapy-naïve setting, which could further displace Jevtana. (Sanofi may have also moved resources from Jevtana to support its recent Zaltrap launch). 

Tasigna® (CML) faces new competition from Bosulif (previously treated CML), which appeared on the scene in early September 2012. The recent movement of Sutent to the 24th position may be due in part to the January 2012 approval of Inlyta, as both of these Pfizer brands are approved for advanced renal cell carcinoma and Inlyta is being targeted for pre-treated patients in a crowded market. (Some of Sutent’s promotion is also directed at GIST and pancreatic neuroendocrine tumors/pNET).

These brands joined the Top 10 list in September 2012: 

  • Xtandi
  • Zaltrap
  • Jakafi

Other recently approved products reported a high level of promotional activity in September:

  • Abraxane was already in 12th place prior to its October sNDA approval
  • Perjeta ranked 17th
  • Inlyta was in 20th position
  • Bosulif appeared in 38th place (with less than a full month of data)

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